Skin disorders can be broadly categorized as those arising from bacterial forms or fungi. Antifungal or antibacterial compositions are traditionally applied as lotions, creams or ointments. Furthermore in many instances, it is difficult to ascertain whether the skin condition is due to a bacterial agent or a fungus.
One approach to treating skin disorders is through elimination by trial and error. Antibacterial or antifungal compositions are applied in turn and response monitored and treatment modified. A major disadvantage of this approach is that treatment needs to be applied many times a day during the treatment period. This is greatly inconvenient and also not cost effective for a majority of human population, particularly in the under-developed nations.
There are several treatments available to treat skin disorders caused by bacteria or fungii. Typically, such compositions use steroids, antibacterial agents or antifungal agents, (or a fixed dose combination of these) and focus on these pharmaceutically active ingredients. The composition of such formulations is such as to enhance their physical/chemical/bio-release profile.
Many skin disorders caused by inflammation and bacterial attacks lead to itching and subsequent scratching, which, among other causes, can in turn lead to serious and complicated secondary infections. The conventionally available treatments do not focus on skin healing or rejuvenation; normally these two aspects are left to heal naturally.
The word healing as related to compromised skin conditions (cuts, wounds, infections, inflammations, abrasions, etc.) are not only about prevention, control, elimination of the source cause such as bacteria or fungi but also to restore the skin to its pre-infection state.
The current approaches of skin treatment can be broadly categorized into two stages, a. healing, and b. restoration of skin to pre-ailment state. The healing part comprises elimination, to the best possible extent, of the root cause of the disorder. This may be elimination of bacteria or fungi causing the infection through a suitable treatment of antibacterial or antifungal agents or reducing the inflammation through steroid treatment. While this treatment is under way, the ongoing compromised condition of the skin continues to be susceptible to secondary infections which can be of quite serious nature. In the case of scratched or wounded skin, it is important for blood clotting to occur quickly as it reduces chances of secondary infections. The focus of such treatments, which are administered through creams, lotions, ointments is on the action of active pharmaceutical ingredients. Cream bases or ointment bases are merely viewed as carriers to take APIs to the sites of disorder.
However, the aspect of restoring the skin back to its pre-disorder state is almost completely left to nature. Therefore one key drawback of the existing skin treatment approaches is that they run the risk of secondary infections due to slow blood clotting and wound healing process.
Furthermore, from the study of the prior art several lacking aspects of the existing prescription derma products used for topical treatment of skin disorders. This is manifested by the fact that the cream base matrix or the ointment base has been overlooked for any potential therapeutic benefits. In particular none of the available prior art suggests that:                Topical skin formulations can deliver skin healing or regeneration beyond the activity of the main APIs such that the therapeutic outcome of the main APIs is enhanced.        The addition of biologically active polymers (the so-called biopolymers) is a complex process in which the stability of the formulations could be compromised if the right biopolymer or naturally interacting formulation excipients or process parameters are not well thought through and optimized to enhance and complement therapy outcomes at the drug design stage itself.        Incorporation of a functionally bio-active excipient polymer in cream matrix while retaining the functional stability of the API in a single dose format of dermaceutical cream involves resolution of problems specific to the physical stability of cream matrix.        
A look at some of the existing patents illustrates the above points.
U.S. Pat. No. 4,803,066 discloses pharmaceutical compositions which are suitable for topical application in the treatment of bacterial and/or fungal infections. The compositions comprise an apparently synergistic mixture of a silver compound and an azole derivative together with a pharmaceutically acceptable carrier therefor. It has been claimed that the compositions may be applied topically in the treatment of burns ulcers and other skin lesions, general skin infections and also in the treatment of infections of the mucous membranes. Preferred compositions according to the application contained silver sulphadiazine and clotrimazole or metronidazole. The patent document also suggests that the compositions may be applied as ointments, gels, pessaries, tablets and the like. At the time of the application of U.S. Pat. No. 4,803,066, the antimicrobial effect of silver ions was well known. However, some authorities believed that resistant organisms may arise and that it would be advantageous to include a second antimicrobial agent along with the silver salt. The inventors of the products disclosed in U.S. Pat. No. 4,803,066 found that by including an azole derivative with a silver salt in a pharmaceutical composition a synergistic antibacterial and antifungal effect is achieved against several important pathogenic organisms. The use of an azole derivative gives an added advantage that the composition may be used against topical fungal infections as well as against topical bacterial infections.
The U.S. Pat. No. 4,460,369 discloses an adhesive-coated liquid-impervious moisture-vapour-permeable thin polymer sheet suitable as a wound covering has an antibacterial, preferably a solid such as silver sulphadiazine, disseminated throughout the adhesive layer, usually in amounts up to 15 wt. %, to provide uniform antibacterial properties over the wound and surrounding skin areas. The problems with bandages have been described as although these are effective in keeping from the wound or surgical site airborne bacteria, there remains the problem of any bacteria which happen to be present in the site or, more commonly, upon the surrounding skin. In the enclosed conditions provided by bandages, such bacteria can multiply unduly and lead to an infection problem. It has been proposed to overcome this by liberal application of bacteriocidal or bacteriostatic cream or like formulation over and around the wound or surgical site. There are, however, disadvantages in this procedure since the film, if subsequently applied over this moist cream base layer, can corrugate with movement of the body and generally does not adhere.
The U.S. Pat. No. 4,460,369 is based upon the realisation that a bacteriostatic or bacteriocidal material can be incorporated into the adhesive layer of the sheet.
The U.S. Pat. No. 4,460,360 accordingly discloses an adhesive-coated sheet material which is liquid-impervious but has a high moisture-vapour permeability whereby it is apparently suitable as a wound or burn dressing, or surgical drape or like wound-covering material, wherein the adhesive coating has disseminated throughout its mass an amount of an antibacterial material sufficient to kill bacteria in the wound and surrounding covered skin area.
As well as preserving adhesion and avoiding corrugation, this invention has apparently two advantages. Firstly, the antibacterial substance being disseminated throughout the adhesive is present in uniform known amount per unit area both over the wound and over its surroundings. Secondly, no additional substrate is needed so that the sheet can be accurately emplaced on the skin. As already stated, it then lies flat on the skin with consequent uniform water vapour transmission and bacterial barrier properties. Also avoidance of corrugations allows retention of protective and healing wound exudate over burns.
These sample cases are sufficient to give a reasonable picture of the way the silver sulphadiazine has been used in the industry.
None of the above mentioned patent applications teach or suggest together:                Use of the cream base matrix as a functional element of the cream rather than a mere carrier for the main APIs        Use a known bio-polymer as a functional excipient along with Silver Sulphadiazine        Providing far superior healing effects as micro-film forming, blood clotting, supporting epidermal growth, microbial electrostatic immobilization take effect simultaneously rather than one after the other as would be the case in conventional single-drug therapy        Improve overall medicinal properties of the cream, complimenting the API used in the cream matrix        
There is therefore a need for a single-dose API topical treatment that will be provided in a cream base, which cream base provides therapeutical value complementary to that provided by the main APIs and serves the purpose over and above that of being a mere carrier or delivery mechanism.